Last updated: July 14, 2026
INTRA-CELLULAR THERAPIES, INC. and related parties sued HETERO USA, INC. in the District of New Jersey (case no. 3:24-cv-08852). The case is a Hatch-Waxman-style patent infringement action tied to an ANDA pathway, but the specific asserted patents, ANDA number, drug product, and claim construction outcomes are not provided in the input. With those elements missing, a complete, accurate litigation-and-patent analysis cannot be produced.
What patents are asserted in INTRA-CELLULAR THERAPIES v. HETERO USA, 3:24-cv-08852?
A complete litigation summary requires the asserted patent numbers and the specific claims at issue. The input contains only the case caption and docket number, not the complaint details (asserted patents, use codes, infringement theory, or requested relief). Without that, the patent issues cannot be enumerated.
Which patents typically appear in these INTRA-CELLULAR THERAPIES ANDA disputes?
In this case category, complaints usually assert a mix of Orange Book-listed composition, formulation, method-of-use, and/or manufacturing patents tied to the brand’s label and the ANDA’s proposed label. That structure cannot be mapped to this docket without the complaint or the infringement chart.
What remedies are typically sought?
Typical Hatch-Waxman complaints seek:
- Injunctive relief barring the ANDA approval and launch during the patent term
- A finding of infringement for each asserted patent
- Damages for past infringement (depending on procedural posture)
The specific prayer for relief in 3:24-cv-08852 is not present in the input.
What is the procedural posture in 3:24-cv-08852?
A litigation posture analysis needs dates and filings such as:
- Complaint filing date
- Answer deadlines
- Markman schedule or claim construction orders
- PTAB status (if any)
- Motion practice (dismissals, preliminary injunction, summary judgment)
- Trial scheduling and any settlement-related dismissal
No docket chronology is included in the input.
Has HETERO USA filed an ANDA in this case?
A Hatch-Waxman infringement case hinges on the ANDA number, the listed patents, and the Paragraph IV or Paragraph III certifications. The ANDA number and certification type are not provided, so the regulatory posture cannot be characterized.
Are there any amendments, stays, or consolidations?
Common developments include amended pleadings, stipulations, and discovery stays. None of that is included in the provided information.
Are there Paragraph IV certifications in this dispute, and what is the launch trigger?
To assess generic entry risk, an analysis must connect:
- The certification (Paragraph IV vs. others)
- The “effective date” timing under 21 U.S.C. § 355(j)
- The asserted patents’ expiration dates
- Any court-ordered 180-day exclusivity effects
The input does not include the certification facts or the relevant patent expiration and exclusivity timeline.
How strong is the patent estate for the asserted product in this case?
Patent-strength scoring requires at minimum:
- Patent family size and remaining term
- Claim scope and prosecution history
- Prior art landscape
- Litigation history of the same patents
The input provides no asserted-patent list, no family membership data, and no claim-level detail.
What generic launch risks exist for HETERO USA from this litigation?
Launch-risk analysis requires:
- Whether the court granted or denied preliminary injunction
- Whether there are stay orders tied to the 30-month stay
- Whether the asserted patents are enforceable and not invalidated
- Whether the final judgment is expected sooner than regulatory milestones
The input does not provide any of these determinations.
How does this case compare with other INTRA-CELLULAR THERAPIES vs. generic defendant filings?
A comparative analysis typically maps:
- Common asserted patents across defendants
- Repeated infringement theories
- Settlement ranges and typical dismissal language
- Shared claim construction results
No information is provided about related cases or overlapping patents.
What settlement outcomes are typical, and what would signal them here?
For Hatch-Waxman cases, settlement signals include:
- Stipulated dismissals with or without prejudice
- Consent judgments
- Narrow licensing agreements with launch carve-outs
- Stays tied to specific study or design-around milestones
The input contains no settlement docket events.
What does FDA regulatory status imply for 3:24-cv-08852?
FDA regulatory status analysis depends on:
- The brand’s NDA/BLA and listed patents on the Orange Book
- The ANDA status, approval status, or submission date
- Exclusivity status (NCE, 505(b)(2), pediatric, etc.)
- Any “section viii” or other amendments
None of these identifiers are included.
Orange Book status: which listed patents are in play?
Orange Book status cannot be calculated without:
- The brand name and dosage form
- The Orange Book patent list and expiration dates
- Which patents the complaint targets
The docket number alone is insufficient to produce a correct Orange Book mapping.
Key Takeaways
- The provided input identifies the case only by caption and docket number (INTRA-CELLULAR THERAPIES, INC. v. HETERO USA, INC., 3:24-cv-08852).
- A litigation summary that is actionable for R&D, licensing, litigation, or investment requires asserted patent numbers, ANDA/Paragraph certification details, and procedural dates.
- Those facts are not included in the input, so the patent and litigation analysis cannot be completed accurately.
FAQs
- What patents are asserted in INTRA-CELLULAR THERAPIES v. HETERO USA, 3:24-cv-08852?
- Which ANDA number and Paragraph IV certification are at issue in 3:24-cv-08852?
- What is the 30-month stay or other FDA-related timing impact from this case?
- Has the court issued a claim construction (Markman) order in 3:24-cv-08852?
- What settlement terms or dismissal events have occurred in 3:24-cv-08852?
References
- PACER docket entry for INTRA-CELLULAR THERAPIES, INC. v. HETERO USA, INC., No. 3:24-cv-08852 (D.N.J.).
